What does GMP (PIC/S) require for personnel training in Australia?

As at September 2026, manufacturers of medicines, APIs and sunscreens must observe the PIC/S Guide to GMP for Medicinal Products (PE009-17, August 25, 2023), excluding Annexes 4, 5 and 14. The TGA adopted this version on September 1, 2025, replacing PE009-16, which had applied since June 3, 2024 (TGA regulatory decision notice).

The legal chain runs as follows. Section 36 of the Therapeutic Goods Act 1989 lets the Minister determine manufacturing principles, which may relate to "the qualifications and experience required of persons employed in the manufacture of therapeutic goods" (s 36(2)(c)) and may include codes of good manufacturing practice. Section 40(4)(a)(ii) makes observing those principles a standard condition of every manufacturing license. The Therapeutic Goods (Manufacturing Principles) Determination 2020, in its compilation from September 1, 2025, defines the PIC/S Guide to GMP as PE009-17.

Everyone whose work could affect product quality must be trained, not only production operators. Paragraph 2.10 of Part I requires training for "all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product" (PIC/S Guide to GMP, Part I).

The Chapter 2 principle sets the baseline: all personnel "should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs." In practice, the population usually includes warehouse staff, engineering and maintenance contractors, cleaners, quality control analysts, quality assurance reviewers and anyone who approves or signs GMP records.

Paragraph 2.13 covers visitors and untrained staff: they should preferably not enter production and quality control areas and, if unavoidable, should be briefed in advance on personal hygiene and protective clothing and closely supervised. Paragraph 2.23 requires consultants to have adequate education, training and experience for the subject they advise on, with records of their name, address, qualifications and type of service.

Training must cover the Pharmaceutical Quality System and GMP in general, plus the specific duties each person performs. Paragraph 2.11 requires basic training on "the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice" and, for new starters, training "appropriate to the duties assigned to them".

• Role specific training (2.11): the procedures, equipment and records each person uses.
• Contamination hazard areas (2.12): specific training for clean areas and areas handling highly active, toxic, infectious or sensitising materials.
• Quality system understanding (2.14): the Pharmaceutical Quality System and measures to improve its understanding and implementation should be "fully discussed during the training sessions".
• Hygiene (2.15): hygiene programs covering health, hygiene practices and clothing, understood and followed "in a very strict way" and widely discussed in training.
• Procedures (1.8): among the basic requirements of GMP, procedures are carried out correctly and operators are trained to do so.

For API manufacture, Part II paragraph 3.12 requires training "regularly conducted by qualified individuals" covering at a minimum the operations the employee performs and GMP as it relates to their functions, with records kept and training periodically assessed (PIC/S Guide to GMP, Part II).

Training programs must be approved by the head of Production or the head of Quality Control, as appropriate (paragraph 2.11). Each of those heads is responsible for ensuring "the required initial and continuing training" of their department is carried out and adapted according to need (paragraphs 2.7(vi) and 2.8(vii)).

Paragraph 2.9 lists training among the responsibilities shared by the heads of Production, Quality Control and, where one exists, Quality Assurance. Above them, paragraph 2.1 requires senior management to provide adequate resources to implement and maintain the Pharmaceutical Quality System. For a training function, this means the approval of each curriculum should be traceable to a named department head, not only to the learning team.

The guide requires that the practical effectiveness of training is periodically assessed and that training records are kept. Paragraph 2.11 states: "Continuing training should also be given, and its practical effectiveness should be periodically assessed."

Chapter 4 (Documentation) reinforces this. Paragraph 4.29 lists "personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training" as matters needing written policies, procedures and records. Paragraph 5.21(x), on cross contamination controls, lists "supervision of working behaviour to ensure training effectiveness". The guide does not prescribe a method, so the manufacturer must define one and apply it consistently, usually through verification of competency such as observed task performance, not attendance alone.

The blood and tissue code is more explicit: clause 212 states that records "should demonstrate that each staff member is trained and competent for the work practices they are authorised to perform" (Australian Code of GMP). Many medicine manufacturers apply the same test when preparing training records for an audit.

The revised Annex 1 adds qualification based training for anyone working in or accessing cleanrooms. Paragraph 7.3 requires all personnel, including cleaning, maintenance and monitoring staff, to receive "regular training, gowning qualification and assessment", including basic microbiology and hygiene, with the level of training based on the criticality of the function and area (PIC/S Guide to GMP, Annexes).

• Gowning qualification (7.4): staff accessing grade A and B areas are trained in aseptic gowning and behavior, with compliance confirmed by assessment and periodic reassessment at least annually, using both visual and microbial assessment.
• Unsupervised access (7.4): restricted to personnel who have passed the gowning assessment and participated in a successful aseptic process simulation (APS).
• Unqualified personnel (7.5): should not enter grade B cleanrooms or grade A in operation except under a written procedure and supervision.
• Disqualification (7.6): systems to disqualify personnel based on ongoing assessment, adverse monitoring trends or a failed APS, with retraining and requalification before return.
• Observation (8.19): aseptic operations, including APS, observed regularly by personnel with aseptic processing expertise to verify correct operator behavior.

The TGA allowed a transition period from September 1, 2025 to March 1, 2026 for the most significant Annex 1 changes, with a staged plan that included commencing staff training on updated clauses. Compliance with all other changes was expected from September 1, 2025 (TGA transition guide). Full implementation has been expected since March 1, 2026.

A practical approach is to map each GMP paragraph to a measurable learning outcome and the evidence an inspector would accept. The table below is an illustrative starting point for a finished dose manufacturer, not TGA guidance; adapt it to your own procedures and training matrix.

Building the matrix from approved standard operating procedures keeps training aligned when a procedure changes. The same logic underpins turning SOPs into training.

A site should be able to show, for any person and any GMP task, that the person was trained, assessed and authorized before doing the task. This checklist summarizes the paragraphs above.

1. A defined training population covering production, storage, laboratories, engineering, cleaning and contractors (2.10).
2. Written training programs approved by the head of Production or Quality Control (2.11).
3. Induction covering the Pharmaceutical Quality System, GMP and hygiene, plus role specific training (2.11, 2.14, 2.15).
4. Specific training for contamination hazard areas, and gowning qualification for sterile areas (2.12, Annex 1 7.3 to 7.4).
5. A documented method for periodically assessing practical effectiveness (2.11, 4.29).
6. Training records linked to authorization to perform tasks and sign records (2.11, 4.29).
7. A change control link so that revised SOPs trigger retraining before the revised procedure is used.

Item 7 is good practice rather than a quoted paragraph, but it is the most common way training falls out of step with procedures between inspections.

Knowledge Foundry models each GMP paragraph, SOP and role as linked concepts with defined assessment points, before training content is written. When a procedure or the adopted PIC/S version changes, the affected roles, outcomes and assessments are identified from the framework, which gives quality leaders a traceable record for inspection.